Senior Supplier Quality Engineer – Medical Devices (Hybrid)

Job Title: Senior Supplier Quality Engineer – Medical Devices Location: Lakewood, CO (Hybrid: 2-3 days onsite) Salary: Depending upon experience, will consider relo reimbursement for the right candidate! Position Overview: Join our team as a Senior Supplier Quality Engineer in the medical device industry! This key role involves managing supplier quality programs, conducting audits, resolving issues, and ensuring compliance with ISO 13485 and FDA QSR. You will drive continuous improvement, support supplier development, and collaborate across teams to ensure the consistent delivery of high-quality components. Responsibilities: Develop and implement supplier quality programs compliant with industry regulations. Conduct audits and assessments to ensure supplier quality systems meet standards. Resolve quality issues and implement CAPA (Corrective and Preventive Actions). Support supplier selection, qualification, and ongoing management. Collaborate with cross-functional teams in new product development and lifecycle management. Monitor supplier performance and present improvements. Qualifications: Bachelor’s degree in Engineering or a related field (advanced degree preferred). 6+ years in Supplier Quality Engineering within the medical device industry. Strong knowledge of FDA, ISO 13485, and ISO 9001 standards. Experience with supplier audits and root cause analysis. Willingness to travel domestically and internationally. Why Join Us? Competitive salary + 7% bonus. Flexible hybrid work schedule. Comprehensive benefits including health, dental, vision, 401(k) matching, and more. Keywords: Supplier Quality Engineer, Medical Device, ISO 13485, FDA QSR, CAPA, Supplier Development, FDA Compliance, Audits, Risk Management, Cross-Functional Collaboration, Root Cause Analysis. If you have monitored supplier quality for these types of components or similar this position may be a great fit for you! Please share details in cover letter or try to have some details on your resume. Plastics: PVC, polypropylene, polyethylene, polystyrene, polyurethane, silicone, and TPE are common for flexible tubing, bags, and other fluid-handling devices. Metals: Stainless steel, aluminum, titanium, and copper are used in durable, structural, or conducting components like centrifuge rotors, needles, and control units. Glass: Used in bioreactors, microfluidic devices, and some filtration components due to its chemical resistance and clarity. Specialty Polymers: For specific applications like microfluidic devices, bioreactors, and sensors, materials like PDMS or nylon are used for their precise characteristics. #M3 #LI-ED1